Effect of Pulsatile IV Insulin on Circulating Risk Markers of Vascular and Metabolic Complications in Pts With Diabetes

NCT00361907 | Terminated Phase 2 DMC

• 2 other identifiers: H09-04MH42900 and MH01386
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of Pulsatile Intravenous Insulin therapy on circulating blood markers. These blood markers are selected due to their correlation to and possible pathogenetic roles in vascular compromise and inflammatory malfunction in diabetic patients.

Conditions

Diabetes Mellitus

Keywords

Pulsatile intravenous insulin; Oral carbohydrate loading; Respiratory Quotients; Hypoglycemia; Diabetic Complications; Circulating vascular and inflammatory markers

Outcome Measures

Primary Outcomes (1)

• Primary: Assessment of effect of Pulsatile Intravenous Insulin therapy on circulating blood markers for diabetic patients.

  Circulating blood markers will be drawn at baseline and every twelve months to monitor and measure results

Study Arms (2)

2

ACTIVE COMPARATOR

Diabetic patients who meet inclusion criteria will be enrolled to start Pulsatile Intravenous Insulin Therapy on a weekly basis. Baseline testing will be performed and measured against continued testing every twelve months.

Procedure: Effect of Pulsatile IV insulin on diabetic pt blood markers

1

PLACEBO COMPARATOR

Circulating blood markers will be performed on diabetic control patients at baseline and every twelve months to compare and measure against patients treated with Pulsatile intravenous insulin therapy

Procedure: Effect of Pulsatile IV Insulin on blood markers; Procedure: Effect of Pulsatile IV insulin on diabetic pt blood markers

Interventions

Effect of Pulsatile IV insulin on diabetic pt blood markers PROCEDURE

Diabetic patients are given pulsatile intravenous insulin on a weekly basis determined by weekly physician order based on pt response and insulin resistance.

Also known as: Humulin, Humulog, Novolog, Epidra

2

Effect of Pulsatile IV Insulin on blood markers PROCEDURE

Circulating blood markers are performed at baseline and every twelve months to compare and measure against diabetic patients receiving pulsatile intravenous insulin.

1

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We will include up to 500 patients both male and female over the age of 21 diagnosed with type 1 or type 2 diabetes mellitus
• All patients must have secondary complications caused by the diabetes and not responding to conventional medical management
• Under an Endocrinologists supervision for their diabetes management
• Endocrinologist must assess and approve patient for participation in this study
• Ability to swallow without difficulty
• Ability to commit to the weekly time requirements associated with the study

You may not qualify if:

• Other causes of complications not related to diabetes
• Lack of intravenous access
• Pregnancy
• Alcohol abuse, drug addiction or the use of illegal drugs
• Positive HIV
• Inability to perform breathe into machine for respiratory quotients

Sponsors & Collaborators

• Florida Atlantic University: lead
• Advanced Diabetes Treatment Centers: collaborator

Study Sites (1)

Florida Atlantic University Center for Complex Systems and Brain Sciences

Boca Raton, Florida, 33431, United States

Location

Related Publications (3)

• Hanke CJ, Drewett JG, Myers CR, Campbell WB. Nitric oxide inhibits aldosterone synthesis by a guanylyl cyclase-independent effect. Endocrinology. 1998 Oct;139(10):4053-60. doi: 10.1210/endo.139.10.6252.

  PMID: 9751482 BACKGROUND

• Mather KJ, Lteif A, Steinberg HO, Baron AD. Interactions between endothelin and nitric oxide in the regulation of vascular tone in obesity and diabetes. Diabetes. 2004 Aug;53(8):2060-6. doi: 10.2337/diabetes.53.8.2060.

  PMID: 15277386 BACKGROUND

• Ellis G, Adatia I, Yazdanpanah M, Makela SK. Nitrite and nitrate analyses: a clinical biochemistry perspective. Clin Biochem. 1998 Jun;31(4):195-220. doi: 10.1016/s0009-9120(98)00015-0.

  PMID: 9646943 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia; Diabetes Complications

Interventions

Insulin, Regular, Human; Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Study Officials

• Betty Tuller, Ph.D

  Florida Atlantic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2006
• First Posted: August 9, 2006
• Study Start: February 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

US (1)